Clinical Research is one of the most critical area in Pharmaceutical industry, which contributes greatly to the effective development of drugs by confirming their efficacy, safety and bio-equivalency. Clinical Research has a vast portfolio which includes innovation of new molecules, discovering new indications, drug design, dosage regimen, the assessment of devices for the administration of drugs, and analyzing the safety of the developed product and determining equivalence against the reference product. The field of Clinical Research involves the development of both innovative and generic products, and the criticality of the studies conducted depends upon the type of pharmaceutical formulation, the safety data provided plus the target therapeutic indications.
Regulatory Authorities have specific requirements and expectations from clinical studies when it comes to the safety and efficacy of the innovative molecules and to demonstrate their bio-equivalency with the reference product along with the application of current Good Clinical Practices (GCP). In addition, Regulatory Authorities also prescribe certain specific requirements in terms of the formats for submitting all the data generated during clinical studies as part of the dossier submission (like Investigational New Drugs [INDs], Investigational Medicinal Product Dossier [IMPDs], Clinical Trial Applications [CTAs], New Drug Applications [NDAs], New Drug Submissions [NDSs], Biological License Applications [BLAs], Abbreviated New Drug Applications [ANDAs], Abbreviated New Drug Submissions [ANDSs], Market Authorization Applications [MAAs]).
Freyr has a competent team of clinical and Regulatory experts to guide Clinical Research Organizations in Regulatory strategic consulting, Regulatory assessment or gap analysis, as well as to assist in the compilation and submission of such dossiers to various Health Authorities (HAs).
- Design assistance for clinical studies for innovative and/ or generic molecules customized as per the requirements of various health authorities
- Assistance in the preparation of study protocols and reports for clinical studies for all types of formulations (solid, liquid, parenteral, inserts) for INDs, NDAs, BLAs, ANDAs, MAA for Global markets (USA, Europe, Latin America [LATAM], Gulf Cooperation Council [GCC], Middle East and North Africa [MENA] and the rest of the world [RoW])
- Compiling and submission of the entire dossier including the quality, efficacy safety and administrative information to Health Authorities across the globe
- Assistance in justifying waivers for bioequivalence (BA/BE) studies and for performing those specific studies if not specified by the health authorities (for Europe)
- Stage-wise review, compilation and submission of all the clinical data generated during the developmental, execution and post-approval stages for biologics, innovations and generics
- Application of the approved clinical studies for specific formulations in order to venture into various markets based on the gap analysis in accordance with the criteria set by various health authorities
- Compilation of the Common Technical Document (CTD) sections, specifically: Clinical Summary (Module 2.5), Non-Clinical Overview (Module 2.4), Non-Clinical Literature Review and Compilation (Module 4), Clinical Literature Review and Compilation (Module 5.4) and Review and Approval of the summaries from clinical and non-clinical experts
- Responding to the health authorities’ queries during the approval and post-approval phases of the product
- Life cycle management of the product related to a clinical point of view (Periodic PADER submissions, ADE report submissions, Annual reports (for US) in addition to the review and compilation of the PSMF (for Europe)
- Customized training for investigators in GCP, assistance in health authority audits and inspections
- Handling medical enquiries, adverse event reporting, preparing the medical review of adverse event reports and periodic literature review